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Analysis on the Registration Application of China New Food Raw Material (Novel Food) in 2021

from CIRS by

Updated on 20 Jan. 2022

China,Food,Registration,Material,Novel

In 2021, the National Health Commission of the People's Republic of China (NHC) issued 3 announcements (No.9, 2020; No.5, 2021; No.9, 2021) for the approval of new food raw materials (novel food), with 8 substances approved.

Besides, the websites of NHC and China National Center for Food Safety Risk Assessment (CFSA) shows that a total of 27 new food raw materials applications were accepted, 6 of public comments on ingredients were issued, and 11 of ingredients review were terminated.

CIRS will take you to the detailed information about the acceptance and approval of new food raw material in China in 2021 as following:

1. List of new food raw material application acceptance in 2021 (27 types)

In 2021, NHC accepted the 27 applications of new food raw material, including 15 domestic products and 12 products. The technical review status of them are shown in the following table.

S/N

Acceptance Date

Acceptance Code

Name

The technical review status

1

25/01/2021

卫食新申字(2021)第0001号

Kanzan flower

Passed the technical review, and issued for public comments (17/08/2021)

2

29/01/2021

卫食新申字(2021)第0002号

Diacylglycerol Oil

Be included in the termination review list

3

03/02/2021

卫食新申字(2021)第0003号

Sodium Hyaluronate

Be included in the termination review list

4

08/03/2021

卫食新申字(2021)第0004号

Pyrroloquinoline quinone disodium(PQQ)salt

Passed the technical review, and issued for public comments (17/08/2021)

5

18/03/2021

卫食新申字(2021)第0005号

Ming Lao(brand) garlic oil

Be included in the termination review list

6

29/03/2021

卫食新申字(2021)第0006号

Seed kernel of Xanthoceras sorbifolium Bunge

Not yet issue for public comments

7

06/04/2021

卫食新申字(2021)第0007号

N-Acetylneuraminic acid(Sialic Acid)

Not yet issue for public comments

8

12/04/2021

卫食新进申字(2021)第0001号

Isomaltodextrin

Not yet issue for public comments

9

19/04/2021

卫食新进申字(2021)第0002号

Leuconostoc pseudomesenteroides

Not yet issued for public comments

10

18/05/2021

卫食新申字(2021)第0008号

Sugarcane Extract

Passed the technical review, and issued for public comments (01/11/2021)

11

18/05/2021

卫食新申字(2021)第0009号

Isodon lophanthoides (Buchanan-Hamilton ex D. Don) H. Hara

Be included in the termination review list

12

18/05/2021

卫食新进申字(2021)第0003号

Bifidobacterium longum BB536

Passed the technical review, and issued for public comments (01/11/2021)

13

19/07/2021

卫食新进申字(2021)第0004号

Corn fermentation product

Not yet issue for public comments

14

02/08/2021

卫食新申字(2021)第0010号

D-Psicose

Not yet issue for public comments

15

09/09/2021

卫食新进申字(2021)第0005号

Elderberry extract

Not yet issue for public comments

16

13/09/2021

卫食新申字(2021)第0011号

Chlamydomonas reinhardtii

Passed the technical review, and issued for public comments (08/12/2021)

17

17/09/2021

卫食新进申字(2021)第0006号

Eggshell membrane powder

Not yet issue for public comments

18

22/09/2021

卫食新进申字(2021)第0007号

Wheat polar lipids

Not yet issue for public comments

19

25/10/2021

卫食新进申字(2021)第0008号

Rye Grass pollen

Not yet issue for public comments

20

26/10/2021

卫食新申字(2021)第0012号

Blueberry extract(Vaccinium croymbosum ‘Lanmei 1’)

Not yet issue for public comments

21

27/10/2021

卫食新申字(2021)第0013号

Microcrystalline Compound Catechin

Not yet issue for public comments

22

15/11/2021

卫食新进申字(2021)第0009号

Imidazole Dipeptide powder from chicken

Not yet issue for public comments

23

22/11/2021

卫食新进申字(2021)第0010号

Olive fruit extract

Not yet issue for public comments

24

22/11/2021

卫食新进申字(2021)第0011号

Marigold extract

Not yet issue for public comments

25

23/11/2021

卫食新申字(2021)第0014号

Leuconostoc mesenteroides subsp. cremoris

Not yet issue for public comments

26

20/12/2021

卫食新申字(2021)第0015号

Coreopsis tinctoria Nutt

Not yet issue for public comments

27

23/12/2021

卫食新进申字(2021)第0012号

Maritime pine bark extract (Pycnogenol®)

Not yet issue for public comments

2. List of new food raw material for public comments released by CFSA in 2021 (6 types)

A total of 6 new food raw materials have passed the technical review by the Expert Review Committee and issued for public comments. However, none of them have been officially approved.

2.1 Lactobacillus acidophilus NCFM (Draft announcement)

Latin Name

Lactobacillus acidophilus NCFM

Other information

1. Approved as a strain that can be used in infant and young children food.

2. Food safety indexes are implemented in accordance with the relevant national regulations.

Issued date

18/02/2021

Public comments on new food raw material--- Lactobacillus acidophilus NCFM

Acceptance date

20/10/2020, 卫食新申字(2020)第0007号

Note: In 2011, Lactobacillus acidophilus NCFM has been included in the”The List of strains that can be used in infant and young children food” and limit its use only for children over 1 year old food, The purpose of this application is to expand the scope for infants under 1 year old.

2.2 Kanzan flower (Draft announcement)

Name

Kanzan flower

Basic information

Species: Cerasus serrulata ‘Sekiyama’

Edible parts: flower

Other information

1. The substance shall not be consumed by infants, pregnant women and lactating women. Inapplicable population should be marked on labels and instructions.

2. Food safety indexes are implemented in accordance with the relevant national regulations of other vegetables products.

Issued date

17/08/2021

Public comments on new food raw material Kanzan flower and Pyrroloquinoline quinone disodium (PQQ) salt

Acceptance date

25/01/2021, 卫食新申字(2021)第0001号

2.3 Pyrroloquinoline quinone disodium (PQQ) salt (Draft announcement)

Name

Pyrroloquinoline quinone disodium(PQQ)salt

Basic information

Molecular formula:C14H4N2Na2O8

Molecular weight:374.17

Brief introduction of production process

Using 6-amino-5-methoxyindole-1H-2-carboxylic acid ethyl ester and dimethyl 2-oxoglutaconate as raw materials, after coupling reaction, formation of quinoline ring, oxidation reaction and hydrolysis reaction of ester and refining.

Recommended intake

≤20 mg/d

Other information

1. Application scope and maximum usage: beverages (40 mg/ kg, solid drinks are converted according to the volume of liquid after preparation).

2. The substance shall not be consumed by infants, young children, pregnant women and lactating women. Inapplicable population should be marked on labels and instructions.

3. See the announcement for details of food safety indicators and test method.

Issued date

17/08/2021

Public comments on new food raw material Kanzan flower and Pyrroloquinoline quinone disodium (PQQ) salt

Acceptance date

08/03/2021, 卫食新申字(2021)第0004号

2.4 Sugarcane Extract (Draft announcement)

Name

Sugarcane Extract

Brief introduction of production process

Using sugarcane as raw material, through squeezing, filtering, sugar separation and other processes to obtain sugarcane molasses, and then water and ethanol are used as extraction solvents to prepare powdered sugarcane extract through processes such as filtration, vacuum concentration, ion exchange and spray drying; or to prepare liquid sugarcane extract through processes such as filtration and vacuum distillation.

recommended daily intake

≤1 g/d(Sugarcane extract powder), or≤10 g/d(Sugarcane extract liquid)

Other information

1. The substance shall not be consumed by infants, pregnant women and lactating women. Inapplicable population should be marked on labels and instructions.

2.See the announcement for details of food safety indicators and quality requirement.

Issued date

01/11/2021

Public comments on new food raw material Sugarcane Extract and Bifidobacterium longum subsp. longum BB536

Acceptance date

18/05/2021, 卫食新申字(2021)第0008号

2.5 Bifidobacterium longum subsp. longum BB536(Draft announcement)

Latin Name

Bifidobacterium longum subsp. longum BB536

Other information

1. A strain that can be used in infant and young children food.

2. Food safety indicators should conform to relevant Chinese standards.

Issued date

01/11/2021

Public comments on new food raw material Sugarcane Extract and Bifidobacterium longum subsp. longum BB536

Acceptance date

18/05/2021, 卫食新进申字(2021)第0003号

2.6 Chlamydomonas reinhardtii (Draft announcement)

Latin Name

Chlamydomonas reinhardtii

Basic information

Family: Chlamydomonaceae, Genus:Chlamydomonas

Brief introduction of production process

It was prepared by Chlamydomonas reinhardtii algae species for breeding, fermenter heterotrophic expansion culture and spray-drying.

Other information

1. The scope of use does not include infant and young children food.

2. Food safety indicators are implemented in accordance with the relevant regulations of algae and algae products.

Issued date

08/12/2021

Public comments on new food raw material--- Chlamydomonas reinhardtii

Acceptance date

13/09/2021, 卫食新申字(2021)第0011号

3. List of approved new food raw material in 2021 (8 types)

There were 8 new food raw materials approved in 2021, the detailed approval information are as follows:

3.1 Isaria cicadae Miq. fruit body (artificial cultivation)

Name

Isaria cicadae Miq. fruit body (artificial cultivation)

Basic information

Source: Artificially grown cicada fruit bodies

Species: Cordyceps, Corynespora

Brief introduction of production process

Inoculate the strain of Isaria cicadae Miq. on culture medium for artificial culture. Then, harvest fruit bodies and dry them.

Recommended intake

≤3 g/day (Measured on dry products)

Supplement information

1. Infants, young children, pregnant women and lactating women are not suitable for consumption. The labels and instructions shall indicate the unsuitable population and the limit of consumption.

2. Using safety standard of edible fungi as reference for contaminant limit, see the announcement for more details.

Issued date

25/11/2019, passed the technical review, and issued for public comments

Approved date

07/01/2021, officially approved by Announcement No.9 of 2020

3.2 Sodium Hyaluronate

Name

Sodium Hyaluronate

Basic information

Source: Streptococcus equi subsp.zooepidemicus

Molecular formula:(C14H20NNaO11)n,n=200–10000
Molecular Weight: 8.02×104–4.01×106

Brief introduction of production process

Using glucose, yeast powder, peptone as the culture medium, fermented from Streptococus equi subsp.zooepidemicus.

Recommended intake

≤200 mg/day

Supplement information

1. Application scope and recommended intake are as follow: Milk and dairy product (0.2 g/kg), Beverages (Volume of liquid beverages≤50 mL, 2.0g/kg, Volume of liquid beverages: 51-500 mL, 0.20 g/kg, Solid beverages are converted according to the liquid volume after preparation), Alcohol (1.0 g/kg), Cocoa products, chocolate and its product (including imitations and chocolate substitutes) and candy (3.0 g/kg), Frozen drinks (2.0 g/kg).

2. Infants, young children, pregnant women and lactating women are not suitable for consumption. The labels and instructions shall indicate the unsuitable population and the limit of consumption.

3. See the announcement for details of food safety indicators.

Acceptance date

23/06/2020, 卫食新申字(2020)第0004号

Issued date

03/09/2020, passed the technical review, and issued for public comments

Approved date

07/01/2021, officially approved by Announcement No.9 of 2020

Note

Sodium hyaluronate’s application was accepted again in 2021(03/02/2021,卫食新申字(2021)第0003号) , but the review has been terminated. Please refer to Table 4 of this article for details.

3.3 Lactobacillus kefiranofaciens subsp. kefiranofaciens

Latin Name

Lactobacillus kefiranofaciens subsp. kefiranofaciens

Supplement information

1. Approved as the edible strain, infants and young children are not suitable for consumption.

2. Food safety indicators should comply with relevant Chinese standards.

Issued date

14/07/2020, passed the technical review, and issued for public comments

Approved date

07/01/2021, officially approved by Announcement No.9 of 2020

3.4 β-1,3-/α-1,3-glucan

Name

β-1,3-/α-1,3-glucan

Basic information

Source: sucrose

Molecular formula: (C6H10O5) n, n≥615

Brief introduction of production process

Using sucrose as raw materials, and produced by Rhizobium pusense fermentation, alcohol precipitation, filtration, separation, drying, crushing and other processes.

Recommended intake

≤3 g/day

Supplement information

1. Infants, young children, pregnant women and lactating women are not suitable for consumption. The labels and instructions shall indicate the unsuitable population and the limit of consumption.

2.See the announcement for details of food safety indicators and test method.

Acceptance date

08/12/2016, 卫食新申字(2016)第0012号, acceptance name is β-1,3-glucan (Sola glue)

Issued date

22/05/2019, passed the technical review, and issued for public comments

Approved date

25/04/2021, officially approved by Announcement No.5 of 2021

3.5 Dihydroquercetin

Name

Dihydroquercetin

Basic information

Source: Pinaceae, Laricoideae, Larix, Sect. Larix, Larix olgensis.

Part: root

CAS: 480-18-2

Molecular formula: C15H12O7

Brief introduction of production process

Using the roots of artificially planted Larix olgensis as raw materials, and produced by the following operations: peeling, tearing, extraction, concentration, alcohol precipitation, supernatant concentration, extraction, re-concentration, crystallization, centrifugation and separation, freeze vacuum drying, crushing and sieving, etc.

Recommended intake

≤100 mg/day

Supplement information

1. Use scope and maximum usage: Drinks: 20 mg/L; Flavored fermented milk: 20 mg/kg; Cocoa product, chocolate and chocolate products: 70 mg/kg.

2. Infants, young children, children (≤14 years), pregnant women and lactating women are not suitable for consumption. The labels and instructions shall indicate the unsuitable population and the limit of consumption.

3. See the announcement for details of food safety indicators.

Issued date

12/11/2020, passed the technical review, and issued for public comments

Approved date

25/04/2021, officially approved by Announcement No.5 of 2021

3.6 Lactobacillus rhamnosus MP108

Latin Name

Lactobacillus rhamnosus MP108

Supplement information

1. The strain that can be used in infant and young children food.

2. Food safety indicators should comply with relevant Chinese standards.

Acceptance date

13/12/2019, 卫食新申字(2019)第0006号

Issued date

12/11/2020, passed the technical review, and issued for public comments

Approved date

25/04/2021, officially approved by Announcement No.5 of 2021

3.7 Nannochloropsis gaditana

Latin Name

Nannochloropsis gaditana

Brief introduction of production process

Produced by inoculation, cultivation, concentration, drying, etc.

Recommended intake

≤2 g/day (dry product)

Supplement information

1. Infants, young children, pregnant women and lactating women are not suitable for consumption. The labels and instructions shall indicate the unsuitable population and the limit of consumption.

2. Food safety indexes are implemented in accordance with the relevant national regulations of edible algae.

Approved date

25/04/2021, officially approved by Announcement No.5 of 2021

3.8 Rumexpatientia L. ×Rumextianshanicus A. Los

Latin Name

Rumexpatientia L. ×Rumextianshanicus A. Los

Basic information

Species: Polygonaceae Juss., Rumex acetosa L.

Edible parts: Stem and leaves

Other information

1. The substance shall not be consumed by infants, pregnant women and lactating women. Inapplicable population should be marked on labels and instructions.

2. Food safety indexes are implemented in accordance with the relevant national regulations of leaf vegetables.

Acceptance date

10/10/2019, 卫食新申字(2019)第0003号

Issued date

12/11/2020, passed the technical review, and issued for public comments

Approved date

22/10/2021, officially approved by Announcement No.9 of 2021

4. List of terminated reviewed products in 2021 (11 types)

A total of 11 new food ingredients were included in the termination review list in 2021( So far, there are 65 products in this list). For new food raw materials, getting the review results of the "substantially equivalent" and "local traditional eating habits" in the termination review is also a way of "getting approval." The review opinions are as follows in the table.

S/N

Product Name

Review Opinions

Acceptance Date and No

1

Eurotium cristatum(CGMCC NO.8730)

The application scope of this strain is tea, and it belongs to the category of "Strains that are traditionally used in food production and processing are allowed to continue to be used" in the The List of Strains That Can Be Used for Food, it is recommended to terminate the review.

29/11/2016,卫食新申字(2016)第0011号

2

Leaf of Strigose Hydrangea

This product has local traditional eating habits, and it is recommended to manage in accordance with Article 29 of the Food Safety Law.

15/08/2017,卫食新申字(2017)第0006号

3

Cardamine circaeoides Hook. f. et Thoms.

This product has a long history of human consumption in many provinces, it is recommended to terminate the review, and refers to the standard management of leaf vegetables: limits of contaminants in food should comply with the regulations of GB 2762, and maximum residue limits of pesticides in food should comply with the regulations of GB 2763.

10/12/2020,卫食新申字(2020)第0009号

4

Haematococcus pluvialis oil(Astaxanthin oil)

Haematococcus pluvialis has been approved as a new resource food. The astaxanthin in this product is basically the same as Haematococcus pluvialis, thus it is recommended to terminate the review. According to the total astaxanthin in Haematococcus pluvialis, the consumption of Haematococcus pluvialis oil is ≤240 mg/day.The total astaxanthin content of Haematococcus pluvialis oil is ≥5%, the ratio of the all-trans astaxanthin content to the total astaxanthin content is ≥70%, and the microcystin- LR, RR, YR should all be less than 1μg/kg. The scope of use does not include foods for infants and young children. The food safety indicators are implemented in accordance with the relevant regulations of vegetable oils.

Acceptance date is unknown, Acceptance No is”卫食新进申字(2019)第0001号”

5

Ming Lao(Brand)

garlic oil

In view of the fact that garlic oil has been listed in the national food safety standard "Standard for Uses of Food Additives" (GB 2760), the main ingredient in this product is caprylic capric triglycerride (>98%) as an approved new food raw material, thus this it is not belongs to the category of new food raw material and it is recommended to terminate the review.

18/03/2021,卫食新申字(2021)第0005号

6

Trollius chinensis Bunge

In view of the fact that there are a variety of single prescriptions and prescription preparations of Trollius chinensis Bunge have been included in the "Pharmacopeia of the People's Republic of China", and it has clear pharmacological activity, thus it is recommended to terminate the review.

24/09/2020,卫食新申字(2020)第0006号

7

L-Arabinose

This product is made from gum arabic as raw material, and is prepared by dilute acid hydrolysis,neutralization, chromatographic separation, desalination, concentration, crystallization, drying and other processes. Substantially equivalent to L-arabinose that has been approved and announced(No.12, 2008). When used as a food raw material, it should be implemented in accordance with the relevant contents of the announced L-arabinose, and the food safety indicators are implemented in accordance with the relevant regulations of sugar.

21/12/2020,卫食新申字(2020)第0010号

8

Diacylglycerol oil 

This product uses olive oil, linseed oil, camellia seed oil, soybean oil, rapeseed oil, peanut oil, corn oil and other edible vegetable oils as raw materials, lipase preparations, water, glycerin, etc. as main auxiliary materials, made by lipase catalysis, distillation separation, decolorization, deodorization and other processes. Substantially equivalent to diacylglycerol oil that has been approved and announced (No.18, 2009). When used as a food raw material, it should be implemented in accordance with the relevant contents of the announced diacylglycerol oil, and the food safety indicators are implemented in accordance with the relevant regulations of vegetable oil.

29/01/2021,卫食新申字(2021)第0002号

9

Sodium Hyaluronate

This product uses glucose, yeast powder, peptone, etc. as the culture medium, and is produced by fermentation of Streptococcus equi subsp. zooepidemicus. Substantially equivalent to diacylglycerol oil that has been approved and announced (No.9, 2020). it is recommended to terminate the review, and is implemented in accordance with the announced sodium hyaluronate.

03/02/2021,卫食新申字(2021)第0003号

10

Milk Minerals

Substantially equivalent to milk minerals that has been approved and announced(No.18, 2009). This product’s quality index is implemented in accordance with product quality specifications, and the health and safety indicators are implemented in accordance with relevant standards.

/

11

Isodon lophanthoides (Buchanan-Hamilton ex D. Don) H. Hara

This product has been approved as a new food raw material for tea beverages, and the application is extended to tea substitute. Based on the provided edible history data and safety assessment data, it was agreed to expand. It is recommended to terminate the review, and the food safety indicators shall be implemented as follows: Lead (calculated as Pb)≤2mg/kg; total Arsenic (calculated as As)≤0.5mg/kg; BHC≤0.02mg/kg; DDT≤0.02mg/ kg.

18/05/2021,卫食新申字(2021)第0009号

Summary

In 2021, a total of 27 new applications were accepted by CFSA, which is more than twice of last year. Meanwhile, the approved products in this year has doubled from last year (a total of 4 products approved in 2020 and a total of 8 products approved in 2021).

As one of the “Three New Foods”, new food raw materials (novel food) have the most strict registration requirements. It usually takes 2 to 3 years from the application acceptance to the final approval. However, it can be found that among 6 substances issued for public comments in 2021, 5 of them were submitted in this year as well , which shows than when the applicant is well prepared, the registration timeline can be greatly shortened.

The new food raw material application timeline depends on its characteristics, usage history, research & development data, and safety assessment data. Enterprises should strengthen their understanding and implementation on regulations and policies, and fully prepared for the application of new food raw materials.

From 2008, NHC officially accepted about 400 applications of new food raw materials, 151 of them were approved, 65 of them were terminated to review. You can contact CIRS Group to obtain the “Guideline on New Food Raw Material Chinese Market Access” to view the complete list of approvals and termination of review.

If you have any needs or questions, please contact us at service@cirs-group.com.

Note: There may be omissions and errors in the data statistics process because of the change of the official website. The data in this article is for reference only. Please refer to the official information published by the government.